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To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

USA116th CongressHR-3443| House 
| Updated: 7/24/2019
Diana DeGette

Diana DeGette

Democratic Representative

Colorado

Cosponsors (3)
Brett Guthrie (Republican)Debbie Dingell (Democratic)Robert E. Latta (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs. The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug. The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval. The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients. The FDA must establish a user fee program for OTC drugs.
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Timeline
Jun 24, 2019
Introduced in House
Jun 24, 2019
Referred to the House Committee on Energy and Commerce.
Jun 25, 2019
Referred to the Subcommittee on Health.
Jul 24, 2019
Sponsor introductory remarks on measure. (CR E971)
  • June 24, 2019
    Introduced in House


  • June 24, 2019
    Referred to the House Committee on Energy and Commerce.


  • June 25, 2019
    Referred to the Subcommittee on Health.


  • July 24, 2019
    Sponsor introductory remarks on measure. (CR E971)

Health

Related Bills

  • HR 116-748: CARES Act
  • S 116-2740: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019
  • HR 116-269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
  • HR 116-19: Lower Costs, More Cures Act of 2019
Administrative law and regulatory proceduresAdministrative remediesChild healthCongressional oversightCosmetics and personal careDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesGovernment studies and investigationsInflation and pricesJudicial review and appealsMarketing and advertisingUser charges and fees

To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

USA116th CongressHR-3443| House 
| Updated: 7/24/2019
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs. The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug. The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval. The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients. The FDA must establish a user fee program for OTC drugs.
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Timeline
Jun 24, 2019
Introduced in House
Jun 24, 2019
Referred to the House Committee on Energy and Commerce.
Jun 25, 2019
Referred to the Subcommittee on Health.
Jul 24, 2019
Sponsor introductory remarks on measure. (CR E971)
  • June 24, 2019
    Introduced in House


  • June 24, 2019
    Referred to the House Committee on Energy and Commerce.


  • June 25, 2019
    Referred to the Subcommittee on Health.


  • July 24, 2019
    Sponsor introductory remarks on measure. (CR E971)
Diana DeGette

Diana DeGette

Democratic Representative

Colorado

Cosponsors (3)
Brett Guthrie (Republican)Debbie Dingell (Democratic)Robert E. Latta (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-748: CARES Act
  • S 116-2740: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019
  • HR 116-269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresAdministrative remediesChild healthCongressional oversightCosmetics and personal careDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesGovernment studies and investigationsInflation and pricesJudicial review and appealsMarketing and advertisingUser charges and fees